A common method of alleviating pain in people suffering from back injuries and promoting healing in post-operative back surgery patients is to stabilize the spine by means of an orthosis, such as a brace. Such braces include a multitude of materials and designs which can be snugly fitted around the patient's trunk. The back portion of such orthosis may also be provided with pockets into which are inserted lordotic pads for treating spinal lordosis.
Such braces are effective in achieving spinal stability if worn properly and consistently; however, most patients have difficulty in manually adjusting the brace to fit tightly enough to provide adequate support. This is especially true in the case of post-operative patients who are generally in pain and frequently lack sufficient strength to make the necessary adjustments. This is also true when the devices cover a large portion of the torso or when materials used in the construction of the orthoses are rigid. For many patients suffering spinal ailments, these braces are also difficult to don, appropriately position and fasten and subsequently remove. This is also particularly true when the devices are large or cumbersome or when they are constructed from rigid materials. In addition, because of the structures of many of these devices and/or the choice of materials used in their construction, the orthoses are quite uncomfortable, in many instances inducing extensive perspiring and/or chafing. Without being consistently worn and properly adjusted, such patient noncompliance obviously reduces the effectiveness of the brace.
Another frequently encountered problem with these types of braces is their inability to conform to the torso as the patient moves from a standing to a sitting position or vice versa. Thus, although such a device may have been properly adjusted initially, the patient is required to make any necessary adjustments manually to vary the tension, depending on whether the patient is standing or sitting. Similar situations and corresponding adjustments may be required as, or shortly after, a meal is consumed or digested. In addition, it is often difficult to adjust the brace to have exactly the same amount of tension that a patient previously found acceptable or even to set a particular tension for a particular patient.
Advances have been made in recent years to provide orthotic devices which can be more easily adjusted to the individual patient and readjusted when their physical position changes. Thus, in U.S. Pat. No. Re 35,940 an electromechanical back brace apparatus is described which is provided with an electromechanical mechanism for tightening the brace around the trunk of the patient to a desired tension. A cable and pulley arrangement is tightened by a small motor to provide the desired tension in the brace. A microprocessor is also provided to control the motor to obtain desired repeatable tension settings. While such a device facilitates rapid and repeatable adjustment of such a brace, the inclusion of an electromechanical mechanism and a microprocessor increases the cost of such a device to a patient or to their medical insurance program. In addition, there is the need to periodically replace batteries to power the electrically operated components.
In some situations larger orthotic devices are necessary either because the portion of the torso being supported constitutes a large volume or because the user of the device is large. In such situations, a single means for tensioning the device over a large area proves somewhat ineffective since the dimensions of the portion of the torso being supported or in which there is contact with the device vary significantly. That is, a single means of adjustment may not provide the necessary conformity to the physical profile of the patient or may provide too little tension or support to achieve the orthotic objectives with respect to a specific portion of the torso while imparting excessive tension or pressure to other parts of the torso.
Accordingly, it is an object of the present invention to provide orthotic devices which result in greater patient compliance since the key to successful orthotic treatment is patient compliance. The attributes of an effective orthotic device which induces patient compliance includes ease of donning an doffing the device, ease of adjusting the device, comfort to the wearer of the device, and effective heat dissipation. More specifically, it is a primary object of this invention to provide orthoses which may be tightened around the torso of a patient to provide the necessary support with the minimal physical effort required on the part of the patient.
It is another object of the invention to provide orthoses which are easily donned and doffed. It is a further object of the present invention to include individual controls for adjustment and custom fitting of different parts of the orthotic device. It is an additional object to provide substantially the same pressure to all portions of the torso supported by the orthosis.
It is another object of the present invention to provide multiple modes of adjustment to achieve individualized adjustment of various portions of orthosis. It is still another object of the present invention to provide multiple and independent means of adjustment of various portions of an orthotic device. It is yet another object of the present invention to provide a rigid back brace apparatus having a significant mechanical advantage that may be individually adjusted to a desired tension and conformity to an individual patient's dimensions.
It is yet another object of the present invention to provide a thoracic lumbar sacral orthosis (TLSO) which is provided with multiple means of adjustment for individually fitting to a patient.
It is another object of the invention to provide an orthotic device which is capable of being rapidly adjusted and, where appropriate, readjusted to an appropriate tension. It is another object of the present invention to provide an orthotic device to be easily disassembled to clean component parts of the device. It is also an object of the invention to provide orthoses which are comfortable and which readily dissipate body heat.